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21 CFR § 111.375 - Under this subpart K, what records must you make and keep?

---
identifier: "/us/cfr/t21/s111.375"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 111.375 - Under this subpart K, what records must you make and keep?"
title_number: 21
title_name: "Food and Drugs"
section_number: "111.375"
section_name: "Under this subpart K, what records must you make and keep?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "FOOD FOR HUMAN CONSUMPTION"
part_number: "111"
part_name: "CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 342, 343, 371, 374, 381, 393; 42 U.S.C. 264."
regulatory_source: "72 FR 34942, June 25, 2007, unless otherwise noted."
cfr_part: "111"
---

# 111.375 Under this subpart K, what records must you make and keep?

(a) You must make and keep records required under this subpart K in accordance with subpart P of this part.

(b) You must make and keep records of the written procedures for manufacturing operations.